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Masters in Regulatory Affairs Summer Institute

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My Experience Meeting Thought Leaders at the George Washington University’s Regulatory Affairs Summer Institute

By Sandee Sidhu

I am enrolled in the GW’s Masters in Regulatory Affairs degree program. For nearly two years, I have been learning about the drug and medical device industry. I took virtual classes, participated in discussion groups, and worked on projects that are relevant to the regulatory profession. I learned a lot, and had the opportunity to interact with members of GW’s faculty and students in my classes.

""This spring, I saw an announcement. GW’s Regulatory Affairs program, in collaboration with the University of Basel’s European Center of Pharmaceutical Medicine (ECPM), was offering a new Summer Institute. The title of the Institute was Issues and Trends in Regulatory Science. The program is blended and included a four-day conference in Washington, DC. It would last from July 11-14, 2016. After weighing the pros and cons of traveling to Washington, I decided to enroll. It was definitely the right decision.

I met an impressive student body. There were MDs, PhDs, regulatory professionals, clinical researchers, and even a healthcare financial analyst. People traveled from all over of the world to participate. The countries that were represented included Switzerland, United Kingdom, Germany, Austria, France, Italy, India, Saudi Arabia and, of course, the United States. We had thought-provoking and multilingual, group lunches and dinners.

Regulatory Affairs Faculty

Doctor Bernadette DunhamThere were prominent people on the faculty. They came from the FDA, the drug and device industry, trade associations, law firms, consulting firms, and GW. We learned about how health care products are cleared for marketing; the future of drug innovation; how the reimbursement process works; and pending legislation that might change the way health care is delivered. We also learned about the efforts of the One Health Initiative to improve health care for people located around the world. Dr. Bernadette Dunham, Visiting Professor at the Milken Institute School of Public Health at GW and Former Director of the Center for Veterinary Medicine at FDA said, “The One Health concept is a worldwide strategy. It recognizes the interconnections of human and animal health with environmental health. No sector of society has enough knowledge and resources to prevent the emergence or resurgence of diseases in today’s globalized world.” I found this fascinating and inspiring.

Touring Federal Agencies in Washington, D.C.

Frank Weichold

We also took a field trip. We toured the FDA headquarters in Silver Spring, Maryland. In addition, we visited the National Institutes of Health and the National Library of Medicine. While at FDA, it was interesting to listen to Dr. Frank Weichold, Director of the Office of Critical Path and Regulatory Science. He said, "Globalization has led to dramatic increases in imports and to highly complex supply chains creating increased opportunities for counterfeit and adulterated products to reach consumers. In response to such challenge, FDA has developed Counterfeit Detection Device (CD3). This is a low-cost, convenient, effective tool to detect counterfeit or adulterated products."

I also enjoyed the presentation from Blair Childs, Senior Vice President of Public Affairs at Premier, Inc. He discussed some of the political realities following the passage of the Affordable Care Act. He explained that private insurers are being incentivized to follow Medicare’s payment and quality models.

The amount and quality of information that I was exposed to was incredible. I agree with a colleague who said, "Michael Morton (Vice President, Corporate Regulatory Affairs at Medtronic) provided a lot of examples from real life experience. This information is not easy to come by – it is beyond useful!"

During the course, I asked Dr. Drago, Director of the Regulatory Affairs Program in the School of Medicine and Health Sciences at GW, why she decided to work with ECPM for this educational offering. She told me that she believes "it is essential to recognize that the advancement and the protection of public health is a global effort. This is not just in terms of collective action, but also in relation to learning from and understanding what is happening in different countries."

Doctor Marr Drago and Doctor Annette MolletAs a student in GW’s Regulatory Affairs Program, I appreciate that the program has many activities in which education and international outreach are central. "The growth of the medical products industry, both domestically and internationally, is resulting in an increased demand for skilled regulatory professionals,” said Dr. Drago. During closing remarks, Dr. Annette Mollet, Head of Education and Training at ECPM, also emphasized that “given the talent shortage, we believe that more can and should be done to harness a reserve of new regulatory talents. The successful collaboration between GW and ECPM gave us the opportunity to develop this one-of-a-kind program."

As the summer institute ended, I knew that it would be valuable to keep in touch with the faculty and classmates. This is one of the most exciting learning experiences I have ever had; one that I will remember for many years to come.

Learn from Experts in Regulatory Affairs

Learn from experts in the field with ties to major agencies that are influential to the shaping of regulatory policy. Engage with experienced Regulatory Affairs leaders within a contemporary curriculum developed with the strategic insight of our program’s Advisory Board that includes members of agencies such as the Food and Drug Administration (FDA).

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